Zimmer Dental Inc: Medical Device Recall in 2017 - (Recall #: Z-0281-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, starter, Ref STRKIT. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.

Product Classification:

Class II

Date Initiated: October 11, 2017

Date Posted: December 27, 2017

Recall Number: Z-0281-2018

Event ID: 78321

Reason for Recall:

The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.

Status: Terminated

Product Quantity: 166 kits

Code Information:

Lot numbers 63688941, 63698713, 63710867, 63726919, 63732673, and 63759854

Distribution Pattern:

Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Belgium, Bulgaria, Chile, Costa Rica, Egypt, France, Georgia, Germany, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Netherlands, Nicaragua, Poland, Portugal, Romania, Serbia, Shanghai, Spain, Taiwan, Thailand, Tunisia, Turkey, UK, and United Arab Emirates.

Voluntary or Mandated:

Voluntary: Firm initiated